Deliberate releases of GMO in Belgium - Databases
This chapter of the Belgian Biosafety Server provides information about genetically modified plants (GMPs) or GMO-medicinal products (GMO-med) that have been notified in Belgium for deliberate release.
For each GMP or GMO-med, the following information can be retrieved, when relevant:
- Description of the deliberate release (based on data obtained from the public dossier)
- Information related to the decision procedure (scientific advices, final decisions) (see further explanation below)
- The "Summary Notification Information Format" (SNIF) (see further explanation below)
- Public information written by the notifier (see further explanation below)
- Relevant guidelines (see further information below)
- Other relevant information
For deliberate releases notified AFTER 21 February 2005
Decision are taken according to the Royal Decree of 21 February 2005. This Decree implements Directive 2001/18/EC repealing Directive 90/220/EEC.
According to the Royal Decree, it is forbidden to proceed to the deliberate release of a GMO into the environment without the prior authorisation (written consent) of the Competent Authority (CA). The standard authorisation procedure is described in Chapter II of the Decree. Accordingly, the CA takes its final decision in particular (i) on the basis of the results of a scientific evaluation of the notification performed by the Biosafety Advisory Council and (ii) on the basis of the results of a 30-days public consultation at the beginning of the procedure.
For deliberate releases notified BEFORE 21 February 2005
The Royal Decree of 18 December 1998 applied. This Decree implemented Directive 90/220/EEC and subsidiary Directives and Decisions.
According to this Decree, it was forbidden to proceed to the deliberate release of a GMO into the environment without the prior authorisation (written consent) of the Competent Authority (CA).
By default the classical authorisation procedure was followed by the notifier. In this case, the final decision of the CA was taken on the basis of the results of a scientific evaluation of the notification performed by the Biosafety
According to Article 9 §1 of the Royal Decision, a single notification was needed for releases of a combination of GMO's on the same site or for releases of the same type of GMO on different sites, provided that these releases were performed in the same goal and during a defined period.
Article 9 §2 of the Royal Decision applied in case of repetition of a deliberate release in the framework of a research programme having already been authorised. In this case, a new notification was needed but the notifier could make reference to informations provided with the previous notification and to the results of the corresponding releases.
Simplified procedure: When enough knowledge, data and sufficient experience had been obtained for certain types of genetically modified plants concerning the necessary prerequisites for safety to human health and the environment, the notifier might request the application of a simplified procedure, according to Article 9 §3 of the Royal Decree. Specific criteria were established (see the Commission decisions 93/584/EEC and 94/730/EC) for experimental releases with transgenic plants. In case of a simplified procedure, the release could be spread over several years and locations. In Belgium distinction was made between the first year and the subsequent years of simplified procedures. For the first year of the simplified procedure one general consent was given by the competent authority after consultation of the Biosafety Advisory Council following the same modalities as for the classical authorisation procedure. For the subsequent years of a release authorised as a simplified procedure, a yearly consent had to be requested from the competent authority, after submission of the exact location and the size of field trials foreseen in that year as well as a report of the releases of the previous year. In that case the evaluation was carried out by the Division of Biosafety and Biotechnology (SBB) that communicated its advice to the competent authority.
(available from 18 October 2002)
Within the framework established by the Directive 2001/18/EC for the exchange of information between the competent authorities and the Commission, the competent authority of the Member State within whose territory the deliberate release is to take place must then send a summary, in accordance with a specific format, of the notification to the Commission, which in turn must forward copies to the other Member States. That "Summary notification information format" (SNIF) reflects the need to enable the fullest possible exchange of relevant information, presented in a standardised and easily comprehensible manner. It is also used by the European Commission to make basic information about the release available to the public.
The databases provide PDF version of SNIFs that have been submitted under Directive 2001/18/EC (e.g. after 17 October 2002).
The complete list of SNIF is available from the JRC Web Site.
(available from 2003)
In Belgium, the Royal Decrees for the deliberate release of GMOs have always foreseen that each notification should contain information intended specifically for the public.
The former Royal Decree of 18 December 1998 (implementing the European Directive 90/220/EEC) provided in article 8§1 that each application for experimental purposes had to contain a proposal of information for the public. In order to give a clear framework to the notifier on how to draft this public dossier, guidelines were set up by the Division of Biosafety and Biotechnology (SBB) in close collaboration with external experts specialised in the field of public information. These guidelines can be found on this website at <http://www.biosafety.be/gmcropff/EN/TP/partB/public_info_dos.htm>.
The new Royal Decree of 21 February 2005 (implementing Directive 2001/18/EC) gives the public dossier a central role in informing citizens. In addition to the SNIF (Summary Notification Information Format) as a mean to inform the public, Article 13§2(g) and Annex VIIIA of the Royal Decree provide that the information intended for the public must at least contain the following elements :
- A didactic description of the GMO;
- The nature and goal of the foreseen deliberate release;
- The framework of research and/or development;
- The potential advantages of the deliberate release;
- The assessment of the potential risks for human health and the environment linked to the deliberate release;
- The proposed measures to limit the potential risks, to control and to ensure follow-up of the deliberate release.
The main objectives of the public dossier is to inform citizens about the activities of companies or research institutes in the biotechnology field and, to stimulate public awareness and education. The delivered information should enable citizens to gather knowledge, to weigh up the risks and benefits, to form a proper opinion about these products, etc. In addition, it is important to pay attention to the accessibility of these public dossiers. The public dossier should be readable and understandable. It is therefore important to use a comprehensible language, which is accessible to everyone. Scientific terminology and concepts should be explained, advertising messages and affirmative statements which are not scientifically founded should be avoided, as these are generally received by the public with suspicion and scepticism, and a good transparent argumentation should be used. The notifier has complete responsibility about the contents of this public dossier. The notifier can be contacted for specific questions or further information as each public dossier contains the co-ordinates of the notifier.
The public dossiers for deliberate releases of genetically modified micro-organisms are available from 2001 for the deliberate release of GM plants and from 2003 for the deliberate release of GM micro-organisms.
Protocols for field releases with transgenic plantsThese protocols provide instructions for the organization from the sowing to the harvest, and the follow up of the parcels where transgenic crops are grown as well as for the waste management of these parcels. Each field trial with transgenic crops needs to be carried out in conformity with the conditions and guidelines stipulated in these protocols taking into account the specific requirements of the consent.
For the moment, protocols exist for transgenic sugar beet, Brassicaceae and chicory. In the future, this initiative shall be extended to other crops (e.g. maize, potato, etc.). The protocols prescribe different acts and operations that the notifier needs to follow. These include the sharing of responsabilities, the keeping of a logbook, the isolation distance and/or isolation border that should be respected, the communication of the sites of release and different operations concerning sowing, planting, harvest, transport, analysis and destruction of the transgenic crop. At the end of the release a report has to be submitted to the competent authority(ies). Also after harvest of the transgenic crop, some guidelines need to be respected. These guidelines indicate which crop can or cannot be cultivated on the trial site in the following rotation, how the potential volunteer plants must be destroyed and how the site of release will be monitored during the following years.
The Belgian competent authority has taken the lead for the co-ordination of the drafting of these protocols, assisted by experts of the Biosafety Advisory Council and the Division of Biosafety and Biotechnology (SBB). The final evaluation and approval is carried out by the Biosafety Advisory Council.
The protocols have been regularly updated since their creation. In the future too, they may continue to develop further in function of the biotechnological developments, the development of regulations, the amassment of knowledge and the expectations of the society.